Open Label Extension Study of Nalbuphine HCl ER in Hemodialysis Patients With Uremic Pruritus

Completed · Phase 2/Phase 3

Conditions studied: Uremic Pruritus, Pruritus

In brief

The primary objective of the study is to evaluate the overall safety of nalbuphine HCL ER tablets during a treatment period of up to 24 weeks.

Key facts

Study ID

NCT02143973

Run by

Trevi Therapeutics

People needed

167

Starts

2014-09-01

Expected to finish

2016-01-01

Last updated by the study team

2025-05-21

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Subject completed participation in the TR02 study
• Subject is currently receiving in-center hemodialysis at the time of consent

You may not qualify if…

• Subject receiving or anticipated to be receiving nocturnal dialysis or home hemodialysis treatment during the study
• Subject received opiates on a daily basis during the 1 week prior to screening
• Other than the TR02 Study Drug, Subject received any investigational drug within 4 weeks prior to Screening
• Subject is a pregnant or lactating female

Where it is running

• Nephrology Associates PC — Birmingham, Alabama, United States
• University South Alabama Medical Center — Mobile, Alabama, United States
• Arizona Kidney Disease and Hypertension Center — Phoenix, Arizona, United States
• U.S. Renal Care Inc. — Pine Bluff, Arkansas, United States
• North America Research Institute — Azusa, California, United States
• Pegasus Dialysis Center — Bakersfield, California, United States
• Central Nephrology Medical Group — Bakersfield, California, United States
• Mark Lee MD, Inc — Whittier, California, United States
• Nephrology and Hypertension Associates PC — Middlebury, Connecticut, United States
• Pines Clinical Research — Pembroke Pines, Florida, United States
• Genesis Clinical Research — Tampa, Florida, United States
• DaVita Central Orlando Dialysis — Winter Park, Florida, United States
• Southwest Georgia Nephrology Clinic PC — Albany, Georgia, United States
• Renal Physicians of Georgia — Macon, Georgia, United States
• Pacific Renal Research Institute — Meridian, Idaho, United States
• Fresenius Medical Care of Evergreen Park — Evergreen Park, Illinois, United States
• Western New England Renal and Transplant Association — Springfield, Massachusetts, United States
• Nephrology Center DBA Paragon Health — Kalamazoo, Michigan, United States
• McComb Limited Care Facility — McComb, Mississippi, United States
• Kidney Associates of Kansas City PC — Kansas City, Missouri, United States
• Nephrology-Hypertension Associates of Central New Jersey PA — North Brunswick, New Jersey, United States
• Renal Medicine Associates — Albuquerque, New Mexico, United States
• Newtown Dialysis Center Inc — Astoria, New York, United States
• Durham Nephrology Associates — Durham, North Carolina, United States
• Wake Nephrology Associates PA — Raleigh, North Carolina, United States

Full record on ClinicalTrials.gov

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